Effect of Shortening the Palatal Extension of the Mouthguard on the Degree of Satisfaction of Water Polo Players
2022年5月24日 更新者：Jordi Martinez-Gomis、University of Barcelona
Effect of Shortening the Palatal Extension of the Mouthguard on the Degree of Satisfaction of Water Polo Players: A Randomized Crossover Study
This study assessed the influence of a reduction of the palate extension of a custom-made mouthguard on the degree of satisfaction of elite water polo players.
Eighteen water polo players wore a custom-made conventional mouthguard or a reduced palate extension mouthguard during the training sessions and for competing for two weeks.
The sequence was randomized to obtain one-half of the participants started the first week wearing the conventional mouthguard, and the other half wearing the shortened mouthguard.
The participants rated the degree of discomfort in reference to speech, breathing, swallowing, nauseas/vomiting, pressure/pain, loosening, aesthetics, and athletic performance, in a 10-point scale, considering 0 no discomfort and 10 maximum discomfort.
After each session, players also rated the perception of protection and the degree of satisfaction in a 10-point scale, considering 0 no protection/satisfaction and 10 maximum protection/satisfaction.
調査の概要
詳細な説明
This crossover intervention study aimed to assess the influence of a reduction of the palate extension of a custom-made mouthguard on the degree of satisfaction of elite water polo players.
Eighteen water polo players participated in this study.
Two different custom-made mouthguards were made, a conventional one and a reduced palate extension mouthguard.
They wore them during the training sessions and for competing one type of mouthguard for the first and fourth week and the other type of mouthguard for the second and third week.
The sequence was randomized to obtain one-half of the participants started the first week wearing the conventional mouthguard, and the other half wearing the shortened mouthguard.
The participants rated the degree of discomfort or inconvenience in reference to speech, breathing, swallowing, nauseas/vomiting, pressure/pain, loosening, aesthetics, and athletic performance, in a 10-point scale, considering 0 no discomfort/inconvenience and 10 maximum discomfort/inconvenience.
After each session, players also rated the perception of protection and the degree of satisfaction in a 10-point scale, considering 0 no protection/satisfaction and 10 maximum protection/satisfaction.
研究の種類
介入
入学 (実際)
18
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Barcelona
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L'Hospitalet de Llobregat、Barcelona、スペイン、08907
- Jordi Martinez-Gomis
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～75年 (大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
Inclusion Criteria:
- water polo players playing in maximum Spanish category for the season 2017-2018
- Obtaining written informed consent for participating in the project (model consent form)
Exclusion Criteria:
- Players with dental caries, with periodontitis or with temporomandibular joint pain
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Conventional mouthguard
Use of a conventional custom-made mouthguard while playing water polo for two weeks.
The conventional mouthguard is designed with the palatal margin at 6 mm from the cervical line.
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Use of a conventional custom-made mouthguard while playing water polo
|
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アクティブコンパレータ：Shortened mouthguard
Use of a shortened custom-made mouthguard while playing water polo for two weeks.
The shortened mouthguard is designed with the palatal margin at 2 mm from the cervical line.
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Use of a shortened custom-made mouthguard while playing water polo
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Degree of satisfaction with the mouthguard
時間枠：Weeks 1-4
|
Participant satisfaction was assessed by asking the question "How satisfied are you with your mouthguard?" using a 0-10 point scale, considering 0= totally dissatisfied and 10= totally satisfied.
Players rated the mouthguard just after each training session or after each match.
|
Weeks 1-4
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Degree of interference on speech while using the mouthguard
時間枠：Weeks 1-4
|
The degree of interference on speech while using the mouthguard was assessed by asking the question "How much do you think wearing the mouthguard interferes your ability to speech?" using a 0-10 point scale (considering 0= Not at all to 10= very much).
Players rated the mouthguard just after each training session or after each match.
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Weeks 1-4
|
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Degree of interference on breathing while using the mouthguard
時間枠：Weeks 1-4
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The degree of interference on breathing while using the mouthguard was assessed by asking the question "How much do you think wearing the mouthguard interferes your ability to breath?" using a 0-10 point scale (considering 0= Not at all to 10= very much).
Players rated the mouthguard just after each training session or after each match.
|
Weeks 1-4
|
|
Degree of interference on swallowing while using the mouthguard
時間枠：Weeks 1-4
|
The degree of interference on swallowing while using the mouthguard was assessed by asking the question "How much do you think wearing the mouthguard interferes your ability to swallow?" using a 0-10 point scale (considering 0= Not at all to 10= very much).
Players rated the mouthguard just after each training session or after each match.
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Weeks 1-4
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Degree of discomfort regarding the gag reflex while using the mouthguard
時間枠：Weeks 1-4
|
The degree of discomfort regarding the gag reflex while using the mouthguard was assessed by asking the question "How much do you think wearing the mouthguard causes a gag reflex?" using a 0-10 point scale (considering 0= Not at all to 10= very much).
Players rated the mouthguard just after each training session or after each match.
|
Weeks 1-4
|
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Degree of discomfort because the mouthguard fits too tight
時間枠：Weeks 1-4
|
The degree of discomfort because the mouthguard fits too tight was assessed by asking the question "How much do you think the mouthguard fits too tight?"
using a 0-10 point scale (considering 0= Not at all to 10= very much).
Players rated the mouthguard just after each training session or after each match.
|
Weeks 1-4
|
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Degree of discomfort because the mouthguard fits too loose
時間枠：Weeks 1-4
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The degree of discomfort because the mouthguard fits too loose was assessed by asking the question "How much do you think the mouthguard fits too loose?"
using a 0-10 point scale (considering 0= Not at all to 10= very much).
Players rated the mouthguard just after each training session or after each match.
|
Weeks 1-4
|
|
Degree of interference on aesthetics while using the mouthguard
時間枠：Weeks 1-4
|
The degree of interference on aesthetics while using the mouthguard was assessed by asking the question "How much do you think wearing the mouthguard interferes on aesthetics?" using a 0-10 point scale (considering 0= Not at all to 10= very much).
Players rated the mouthguard just after each training session or after each match.
|
Weeks 1-4
|
|
Degree of interference on athletic performance while using the mouthguard
時間枠：Weeks 1-4
|
The degree of interference on athletic performance while using the mouthguard was assessed by asking the question "How much do you think wearing the mouthguard interferes athletic performance?"
using a 0-10 point scale (considering 0= Not at all to 10= very much).
Players rated the mouthguard just after each training session or after each match.
|
Weeks 1-4
|
|
Degree of protection with the mouthguard
時間枠：Weeks 1-4
|
The degree of protection perceived by the participant was assessed by asking the question "How much do you feel protected when you are wearing the mouthguard?" using a 0-10 point scale (considering 0= Not at all to 10= very much).
Players rated the mouthguard just after each training session or after each match.
|
Weeks 1-4
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Zamora-Olave C, Willaert E, Montero-Blesa A, Riera-Punet N, Martinez-Gomis J. Risk of orofacial injuries and mouthguard use in water polo players. Dent Traumatol. 2018 Dec;34(6):406-412. doi: 10.1111/edt.12434. Epub 2018 Oct 10.
- Gebauer DP, Williamson RA, Wallman KE, Dawson BT. The effect of mouthguard design on respiratory function in athletes. Clin J Sport Med. 2011 Mar;21(2):95-100. doi: 10.1097/JSM.0b013e31820428b0.
- Maeda Y, Machi H, Tsugawa T. Influences of palatal side design and finishing on the wearability and retention of mouthguards. Br J Sports Med. 2006 Dec;40(12):1006-8. doi: 10.1136/bjsm.2006.030874. Epub 2006 Sep 25.
- Lloyd JD, Nakamura WS, Maeda Y, Takeda T, Leesungbok R, Lazarchik D, Dorney B, Gonda T, Nakajima K, Yasui T, Iwata Y, Suzuki H, Tsukimura N, Churei H, Kwon KR, Choy MMH, Rock JB. Mouthguards and their use in sports: Report of the 1st International Sports Dentistry Workshop, 2016. Dent Traumatol. 2017 Dec;33(6):421-426. doi: 10.1111/edt.12375.
- Parker K, Marlow B, Patel N, Gill DS. A review of mouthguards: effectiveness, types, characteristics and indications for use. Br Dent J. 2017 Apr 21;222(8):629-633. doi: 10.1038/sj.bdj.2017.365.
- Gomez-Gimeno A, Zamora-Olave C, Cordobes-Navarro M, Willaert E, Martinez-Gomis J. Satisfaction with shortening the palatal extension of a mouthguard for water polo players: A randomized crossover study. Dent Traumatol. 2019 Apr;35(2):135-141. doi: 10.1111/edt.12455. Epub 2019 Jan 7.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2018年3月1日
一次修了 (実際)
2018年5月15日
研究の完了 (実際)
2018年6月15日
試験登録日
最初に提出
2018年9月10日
QC基準を満たした最初の提出物
2018年9月22日
最初の投稿 (実際)
2018年9月26日
学習記録の更新
投稿された最後の更新 (実際)
2022年5月27日
QC基準を満たした最後の更新が送信されました
2022年5月24日
最終確認日
2022年5月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- HOUB2018/004
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
未定
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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